Amy (Skydel) Pinette is an esteemed leader in the biotechnology and pharmaceutical industry, with a distinguished career marked by her ascent to high-level executive roles. With over three decades of experience, Amy has consistently demonstrated her expertise in clinical operations, program management, and cross-functional team leadership.

At uniQure, she served as Senior Director of Global Clinical Operations, where she played a pivotal role in advancing gene therapy research and driving operational excellence across clinical trials. Her tenure at Parexel saw her rise from Portfolio Director to Senior Client Relationship Director, a testament to her adeptness at managing complex global programs and fostering client relationships. Amy’s strategic vision and dedication were instrumental in navigating the intricacies of clinical study management and regulatory compliance within the neuroscience domain at inVentiv Health Clinical (formerly i3Research).

Earlier in her career, Amy made significant contributions to CNS-focused research at Premier Research (formerly SCIREX) where she held senior directorial positions. Her foundational years at Bristol-Myers Squibb as a CRA honed her skills in clinical research and paved the way for her future leadership roles.

Amy’s academic background is equally impressive, with a Bachelor of Science in Biology from McGill University followed by a Master’s degree in Neuroscience from the University of Hartford. This solid educational foundation underpins her extensive professional achievements.Throughout her career, Amy has been recognized by colleagues for her infectious enthusiasm, forward-thinking approach, and ability to inspire teams under high-pressure situations. She is known for seeing solutions where others see problems and has earned accolades for leading teams to meet goals efficiently.

Amy has organized consulting/advisory boards, data safety monitoring committees, and other such teams. Beyond her operational acumen, Amy possesses deep expertise in various therapeutic areas, primarily neuroscience. Her knowledge extends to vital industry standards such as process management and efficiency, SOP and process development, ICH/GCP, global regulatory requirements, and inspection readiness.

She is also skilled in various aspects of clinical trial management systems. As she seeks new adventures contributing to clinical ops or program management success, Amy’s legacy is one of inspirational leadership and unwavering commitment to advancing medical research. In addition to the above, Amy has been a part of the lay leadership at her synagogue for upwards of 30 years. She has held various committee leader and board positions; her most recent role was as President of the Board of Trustees of this 300+ member community.

Amy’s leadership of this non-profit institution includes budget management, by-laws review and update, hiring decisions, grant application preparations, security planning and implementation, and the like. Her ability to balance the business of the synagogue with the religious needs of a sacred community has earned her accolades from the congregation and clergy. Amy is also involved in grant application review and decision making for the Greater Hartford Jewish Federation.

Character: Amy Pinette is known for her integrity and dedication to advancing clinical research, consistently demonstrating strong leadership and resilience in complex environments. Her commitment to patient advocacy and ethical practices underpins her approach to clinical operations.

Knowledge: With over 30 years of experience in clinical operations, Amy possesses deep expertise in biotech and pharma, specializing in program management and cross-functional team leadership. Her knowledge spans across various therapeutic areas and includes proficiency in regulatory submissions and clinical trial management.

Strategic: Amy excels in devising and implementing strategic plans that streamline clinical operations and enhance program efficiency. Her ability to manage large-scale projects and collaborate with stakeholders ensures successful execution of complex clinical programs.

Communication: Amy’s effective communication skills enable her to build strong relationships with clients, vendors, and team members. Her adeptness in presenting complex information and facilitating discussions contributes to successful project outcomes and stakeholder engagement.